Recall: Legal Definition

A recall is the removal of a medical device from the market because the product is defective, poses a safety risk to users, or is in violation of U.S. Food and Drug Administration (FDA) laws.

A manufacturer or distributor must notify the FDA of any medical device recalls. If a manufacturer refuses to voluntarily remove a defective and dangerous medical device from the market, the FDA can issue a recall order forcing the manufacturer to remove the product.

Hernia Mesh Recalls

In recent years, manufacturers of hernia mesh products have issued recalls after receiving reports of the medical devices failing and harming patients. Surgical mesh comes in a variety of shapes and sizes and is used to repair different types of hernias. 

One major recall involved the Kugel hernia mesh patch manufactured by Davol Inc., a subsidiary of C. R. Bard, Inc. The mesh, used to repair hernias in the abdominal wall, was first recalled in 2005.

In 2006, Davol Inc. recalled certain sizes of the mesh patch because of the potential for the memory recoil ring to break. This defect caused patients to suffer serious injuries. The recall was expanded in 2007.

The FDA designated the recall as “Class 1,” the federal agency’s classification for dangerous and defective products that can cause serious injuries or death.

Recall vs. Market Withdrawal

A company may initiate a “market withdrawal” of a medical device. Unlike a recall, a market withdrawal involves only a minor FDA violation or no FDA violation at all.

Manufacturers have various reasons for withdrawing a device. For instance, in 2016, Ethicon Inc., a subsidiary of Johnson & Johnson, removed its Ethicon Physiomesh Flexible Composite Mesh from the global market.

The company found the mesh had high hernia recurrence and revision surgery rates. Because Ethicon could not explain the high failure rate, the company suspended sales of the device.

Recalled Hernia Mesh Lawsuits

Plaintiffs have filed thousands of lawsuits nationwide over recalled hernia mesh products.

For instance, lawsuits have been consolidated in the federal district court in the Southern District of Ohio over C. R. Bard, Inc.’s polypropylene hernia mesh products.

Similarly, lawsuits have also been consolidated in the federal district court in Northern Georgia over Ethicon’s Physiomesh Flexible Composite Hernia Mesh.

Patients implanted with the recalled hernia mesh are seeking compensation for costs for revision surgeries, lost income, pain and suffering, and other damages.

Injured by Recalled Hernia Mesh? The Law Offices of Ogle, Elrod & Baril PLLC Can Help

If you suffered injuries from a hernia mesh product, or if your loved one died because of complications following hernia repair surgery, contact the Law Offices of Ogle, Elrod & Baril, PLLC.

Our hernia mesh complication lawsuit lawyers can help you pursue compensation for the financial losses you suffered because of hernia mesh devices.

We work on a contingency fee basis, which means you do not pay us unless we win compensation in your case.

Call 865-546-1111 today for a free case review.